| Audit Number |
Region |
Material |
Company |
Location |
Audit Date |
Materials |
| JA-0019 |
United States |
API |
AMPAC Fine Chemicals |
Rancho Cordova, CA |
12-13 July 2011 |
GMP Audit |
| JA-0001 |
United States |
Excipient |
Avantor |
Phillipsburg, NJ |
13-14 April 2011 |
1. HCl - Acids Bldg 94
2. Benzyl Alcohol - Bldg 97
3. Potassium Phosphate Monobasic - Multi Compendial (RE) - Bldg 110
4. Potassium Nitrate - Large Stainless Steel Train (LSST) |
| JA-0009 |
United States |
Excipient |
FMC Corporation |
Newark, DE |
24-25 May 2011 |
1. Croscarmellose Sodium NF
2. Microcrystalline Cellulose NF
3. Aquacoat ECD |
| JA-0020 |
United States |
Excipient |
ISP Corp. |
Texas City, TX |
14-15 September 2011 |
1. Polyplasdone, XL-10
2. Polyplasdone XL
3. Plasdone K-29/32 |
| JA-0003 |
United States |
Basic Chemical/Raw Material |
Sigma-Aldrich |
St. Louis, MO |
4-5 May 2011 |
1. T1503, Trizma base 99.9%
2. H3375 HEPES >99.5% |
| JA-0002 |
Asia |
API |
Hovione |
Macau, China |
13-15 July 2011 |
1. Doxycycline
2. Ivermectin
3. Roxithromycin |
| JA-0011 |
Asia |
Intermediate |
Aurisco |
Shanghai, China |
30 May - 1 June 2011 |
1. Betamethasone
2. Flumethasone |
| JA-0012 |
Asia |
API |
Hikal |
Bangalore, Karnataka India |
17-19 May 2011 |
1. Gabapentin
2. Tripolidine |
| JA-0013 |
Asia |
API |
CSPC Innovation Pharmaceutical Co. Ltd. |
Heibei Province, P.R. China |
23-25 May 2011 |
1. Caffeine |
| JA-0016 |
Asia |
Basic Chemical/Raw Material |
Showa Kako |
Osaka, Japan |
16 May 2011 |
1. 2-mercapto-5-methoxy benzimidazole |
| JA-0010 |
Europe |
API |
Boehringer-Ingelheim |
Ingelheim am Rhein, Germany |
24-26 May 2011 |
1. Digoxin
2. Phenylephrine HC1
3. Adrenaline Tartrate/ Epinephrine Hydrogenotartrate |
| JA-0004 |
Europe |
API |
GSK |
Scotland, UK |
13-14 September 2011 |
1. Potassium Clavulanate |
| JA-0006 |
Europe |
API |
Merck KGaA |
Darmstadt, Germany |
16-18 May 2011 |
1. Methylglucamine (Meglumin)
2. Magnesium Chloride |
| JA-0018 |
Europe |
API |
Labochim |
Milan, Italy |
28-29 September 2011 |
1. Diclofenac Sodium
2. Propentofylline |
| JA-0008 |
Europe |
API |
DSM Nutritional Products |
Sisseln and Van Neuf, Switzerland |
27-29 June 2011 |
1. DL-ALPHA TOCOPHEROL
2. PALMITATO VITAMINA A (P 1.7)
3. DL-Alpha-Tocopheryl acetate
4. Cholecalciferol E.P. (Vit.D3)
5. BETA-CAROTENE 1%CWS |
| JA-0005 |
Europe |
Excipient |
BASF |
Ludwigshafen, Germany |
5-6 May 2011 |
1. Povidone
2. Copovidone
3. Crospovidone |
| JA-0007 |
Europe |
Excipient |
Merck KGaA |
Darmstadt, Germany |
16-18 May 2011 |
1.1.03583 PARTECK SI 150 (SORBITOL)
2. 1.12635 PARTECK DELTA M (MANNITOL)
3. 1.06482 SODIUM HYDROXIDE PELLETS
4. 1.08881 ZINC SULFATE, HEPTAHYDRATE
5. 1.05832 MAGNESIUM CHLORIDE, HEXAHYDRATE CRYSTALS |
| JA-0015 |
Europe |
Basic Chemical/Raw Material |
Sigma-Aldrich |
Buch, Switzerland |
2-3 August 2011 |
1. Benzenesulfonic acid
2. N-Acetyl-DL-tryptophan |
| JA-0017 |
Europe |
Chromatography Resins |
GE Healthcare |
Uppsala, Sweden |
4-5 October 2011 |
1. Q Sepharose Fast Flow
2. MabSelect |
| JA - 0022 |
United States |
Excipients |
Capsugel |
Greenwood, SC |
27-28 March 2012 |
1. Empty hard gelatin capsules, type Coni-Snap, in different sizes and colors with/without imprints
2. HPMC empty hard capsules, type VcapsPlus, in different sizes and colors with/without imprints
3. Empty hard gelatin capsules, type DB-caps, different sizes and colors with/without imprints
4. Empty hard gelatin capsules, type Licaps, different sizes and colors with/without imprints
5. Empty hard gelatin capsules, 100% bovine, type Coni-Snap
6. “Halal” Empty hard gelatin capsules, type DB caps |
| JA - 0025 |
United States |
Excipients |
Avantor Performance Materials |
Paris, Kentucky |
5-6 June 2012 |
1. Calcium Chloride Dihydrate, granulate (mat. 4616)
2. Edetate Disodium Dihydrate (mat. 7727, mat. 1395)
3. Hydrochloric Acid, diluted (mat. 2608) ,Hydrochloric Acid, 6N (mat. 0327)
4. Magnesium Chloride 6*Hydrate, crystal (mat. 2449)
5. Mannitol powder (mat. 2553)
6. Polysorbate 80 (mat. 4117)
7. Potassium Chloride, granular (mat. 6838)
8. Potassium Chloride, crystal (mat. 6845)
9. Potassium Phosphate Monobasic, crystal (mat. 3248, mat. 7096)
10. Sodium Phosphate Monobasic, Monohydr., granular (mat. 7868)
11. Sodium Chloride, granular (mat. 3627, mat. 7713)
12. Sodium Citrate Dihydrate, crystal (mat. 0734, mat. 7773)
13. Sodium Hydroxide, 5N Solution (mat. 0895)
14. Sodium Phosphate Dibasic 7*Hydrate (mat. 3803, mat. 3816) |
| JA - 0036 |
United States |
Primary Packaging |
Barnhardt Manufacturing Co. Carolina Absorbent Cotton |
Pomfret Center, CT |
19-20 June 2012 |
Pharmaceutical: Coil Cotton, Rayon, Polyester |
| JA - 0046 |
Europe |
APIs, Excipients |
Chemische Fabrik Budenheim |
Budenheim, Germany |
17-18 July 2012 |
API’S
1. Calcium phosphate
2.Sodium Phosphate
EXCIPIENTS
1. Calcium hydrogenphosphate
2. Magnesium hydrogenphosphate
3. Calcium Hydrogen Phosphate Dihydrate |
| JA - 0079 |
United States |
Excipients, Basic Chemicals / Raw Materials |
Morton Salt (Excipient Mfg Location) |
Rittman, OH |
8-9 May 2012 |
Sodium Chloride, USP |
| JA - 0100 |
United States |
Basic Chemicals / Raw Materials |
West Pharml Services, Inc. |
Lititz, PA |
17 May 2012 |
5 mL 13mm diameter glass vials |
| JA - 0111 |
United States |
APIs |
International Specialty Products (ISP) |
Calvert City, KY |
10-11 July 2012 |
1. Povidone (ISP Plasdone K-90 & Plasdone K-29/32)
2. Crospovidone (ISP Polyplasdone XL & Polyplasdone XL-10)
3. Povidone Iodine (ISP PVP Iodine), |
| JA - 0114 |
Europe |
Printed Components |
Packetis |
Chazelles, France |
12 July 2012 |
Boxes |
| JA-0117 |
United States |
Basic Chemica/Raw Material |
Sartorius Stedim |
Yauco, Puerto Rico |
14-15 August 2012 |
Bioprocess Bags |
| JA - 0042 |
United States |
Excipients |
Biospectra (Excipient Mfg Location) |
Stroudsburg, PA |
28-29 August 2012 |
Printed Materials |
| JA - 0047 |
United States |
Primary Packaging |
Chesapeake Pharmaceutical Packaging |
Raleigh, NC |
14-15 August 2012 |
1. Tris base 4102
2. Tris hydrochloride 4106-07
3.Tris and Guanidine
4.Tromethamine, USP |
| JA - 0069 |
Canada |
Excipients |
Innophos |
Port Maitland, Ontario |
16-17 October 2012 |
1. Tetrasodium Pyrophosphate
2. Sodium Pyrophosphate
3. Tetrasodium Phosphate |
| JA - 0093 |
Europe |
Primary Packaging |
Schott Pharmaceutical (ACM) |
Mulheim, Germany |
12 September 2012 |
50 cc vials |
| JA - 0094 |
United States |
Basic Chemicals / Raw Materials |
SAFC Biosciences (Broadway) |
St. Louis, MO |
TBD January 2013 |
1. 1% Simethicone
2. Selenious Acid
3. L-Tyrosine |
| JA - 0104 |
Europe |
Primary Packaging |
Amcor Flexibles |
Singen, Germany |
8 August 2012 |
1. Aluminium Foil
2. Sachet Foil
3. Formable Web Material |
| JA - 0026 |
Europe |
APIs |
BASF Pharmachemikalien GmbH |
Minden, Germany |
26-27 September 2012 |
1. Theophylline Anhydrous
2. Caffeine anhydrous
3. Ephedrine
4. Pseudoephedrine
5. Oxymetazoline
6. Dopamine
7. Theophylline |
| JA-0106 |
Europe |
API |
Bidachem |
Fornovo S. Giovanni, Italy |
12-13 February 2013 |
1. Crotamiton
2. Bisacodyl |