FDA Inspection 1093590 — T.C. Bauer Co.
The FDA completed an inspection of T.C. Bauer Co. on March 14, 2017 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15966 | 21 CFR 111.117(a) | Quality control operations - calibrating processes |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |