BIOLOGISCHE HEILMITTEL HEEL GMBH
Form 483 issued February 1, 2019 · Baden Baden, Germany
- Inspection
- Jan 24 – Feb 1, 2019
- Investigator
- Arsen Karapetyan
- Observations
- 7
- Pages
- 10
- FEI number
- 3002806504
In short: On February 1, 2019, FDA issued a Form 483 with 7 observations to BIOLOGISCHE HEILMITTEL HEEL GMBH in Baden Baden, Germany (FEI 3002806504) after an inspection that ran Jan 24 – Feb 1, 2019. The investigator was Arsen Karapetyan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.160(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
drug products were not tested for the presence of 2 when a reasonable possibility existed that…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Established specifications, test procedures and laboratory control mechanisms are not followed and documented at…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmBIOLOGISCHE HEILMITTEL HEEL GMBH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BIOLOGISCHE HEILMITTEL HEEL GMBH?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected BIOLOGISCHE HEILMITTEL HEEL GMBH?
Arsen Karapetyan is named on this Form 483, for the inspection of Jan 24 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was BIOLOGISCHE HEILMITTEL HEEL GMBH inspected by FDA?
The inspection ran Jan 24 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
How do I get the full Form 483 for BIOLOGISCHE HEILMITTEL HEEL GMBH?
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