FDA Inspection
McGuff Pharmaceuticals, Inc.McGuff Pharmaceuticals, Inc. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns McGuff Pharmaceuticals, Inc., with an inspection on March 31, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · 5fff839d-7396-49b4-a06d-b1c8c086c1f0
Inspection Facts
- Inspection number
- 1010923
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.122(e)Destruction of obsolete labeling
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(1)Sample identification and other information
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Other FDA inspections of McGuff Pharmaceuticals, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| August 20, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 26, 2024 | VAI | Los Angeles District Office | New Drug Evaluation |
| November 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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