FDA Inspection
Pentec HealthPentec Health – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Pentec Health, with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christina K. Theodorou (FDA Associated Person)
- Lisa B. Orr (Issuing Officer)
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ID · 8998f4d7-6bcb-45c3-8146-56b6751401f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041967
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Pentec Health
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2019 | Not classified | Philadelphia District Office |
Other documents for Pentec Health
- FDA Inspection 1102417 - 2019-05-30
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