FDA Inspection
Biocon Sdn. Bhd. (Company No. 201101002193)Biocon Sdn. Bhd. (Company No. 201101002193) – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns Biocon Sdn. Bhd. (Company No. 201101002193), with an inspection on July 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- July 5, 2019
- Product Type
- Human Drugs
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ID · 98e8c3b6-2b72-4518-a546-ef9ba83036c9
Inspection Facts
- Inspection number
- 1095222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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Other FDA inspections of Biocon Sdn. Bhd. (Company No. 201101002193)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | Not classified | Office of Inspections and Investigations | |
| July 20, 2023 | Not classified | Office of Inspections and Investigations | |
| February 15, 2018 | Not classified | Office of Inspections and Investigations |
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