FDA Inspection
Haupt Pharma Wuelfing GmbHHaupt Pharma Wuelfing GmbH – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Haupt Pharma Wuelfing GmbH, with an inspection on August 10, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Lisa B. Orr (Issuing Officer)
- Sateesh Kum Sathigari (Issuing Officer)
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ID · a2c39edb-90a8-4e62-b319-5d0670c5e908
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061723
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Haupt Pharma Wuelfing GmbH
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Haupt Pharma Wuelfing GmbH
- FDA Inspection 1275631 - 2023-06-06
- FDA Inspection 1088285 - 2018-12-07
- FDA Inspection 1009773 - 2017-03-17
- FDA Inspection 931397 - 2015-06-16
- FDA Inspection 877801 - 2014-03-28
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