FDA Inspection
PenCef Pharma GmbHPenCef Pharma GmbH – FDA Inspection, Sep 27, 2023
Record Details
This FDA Inspection record concerns PenCef Pharma GmbH, with an inspection on September 27, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 5db09449-1db1-4051-a1e3-1b18bb591fa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219959
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of PenCef Pharma GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2017 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
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