FDA Inspection
Pharmaceutics International, Inc.Pharmaceutics International, Inc. – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns Pharmaceutics International, Inc., with an inspection on March 6, 2026, issued by the Baltimore District Office, covering human drugs.
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ID · 357b9f0b-0f0d-44ec-abbf-4c4b6f1cde63
Inspection Facts
- Inspection number
- 1307080
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Pharmaceutics International, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmaceutics International, Inc.
- FDA Inspection 1244595 - 2024-06-12
- FDA Inspection 1194409 - 2022-11-14
- FDA Inspection 1155191 - 2021-09-29
- FDA Inspection 1124545 - 2020-07-10
- FDA Inspection 1072073 - 2018-11-09
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