FDA Inspection 1220650 — Aromas Para El Alma S.A.
The FDA completed an inspection of Aromas Para El Alma S.A. on October 19, 2023 in Guachipelin, San Rafeal, Escazu. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 19, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guachipelin, San Rafeal, Escazu (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |