Drug factory · FDA FEI 3004058163
Sintetica S.a.
VIA PENATE 5, Mendrisio, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Nov 9, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alcohol | Makes it, tests it, packages it and labels it | BPI Labs, LLC, Belcher Pharmaceuticals,LLC | 54288-105, 62250-105 |
| Epinephrine | Makes it, tests it, packages it and labels it | BPI Labs, LLC | 54288-103 |
| Lidocaine | Makes it, tests it, packages it and labels it | Sintetica Sa, Sintetica US LLC | 68055-641, 68055-642, 68055-643 +11 |
| Phenylephrine | Makes it, tests it, packages it and labels it | Dr. Reddy's Laboratories Inc., Eton Pharmaceuticals, Inc. | 43598-172, 43598-199, 71863-202 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 9, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 17, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 21, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 9, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 28, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 6, 2016 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Protection from external factors 21 CFR 211.94(b)
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
Nov 21, 2014 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Registered with FDA for: analysis; label; manufacture; pack.