Frank Wackes
FDA investigator
Appears on 2 documents from 2015 to 2017, mostly at sites in Missouri. Most often cites design controls (21 CFR 820.30).
- 2
- Documents on file
- 9.5
- Observations per 483
- 2015
- First seen
- 2017
- Most recent
What they cite most
From 19 observations- 21 CFR 820.30Design controls4
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
Activity by year
2015: 1, 2017: 1
Where
Missouri 1 · New York 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-03-24 | 483 Meridian Medical Technologies, Inc. a Pfizer CompanyMar 24, 2017 · Brentwood, Missouri | Brentwood, Missouri | 14 | |
| 2015-05-22 | 483 Curia New York, Inc.May 22, 2015 · Rensselaer, New York | Rensselaer, New York | 5 |
About this profile
What does Frank Wackes inspect?
Frank Wackes appears on 2 documents on file covering 2 sites, mostly in Missouri.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 211.160 and 21 CFR 211.192.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Frank Wackes is dated Mar 24, 2017.