LTS Lohmann Therapy Systems Corp.
Form 483 issued June 11, 2019 · West Caldwell, New Jersey
- Inspection
- Jun 4 – Jun 11, 2019
- Investigators
- Emmanuel J. Ramos· Lata Mathew
- Observations
- 2
- Pages
- 3
- FEI number
- 1000121692
In short: On June 11, 2019, FDA issued a Form 483 with 2 observations to LTS Lohmann Therapy Systems Corp. in West Caldwell, New Jersey (FEI 1000121692) after an inspection that ran Jun 4 – Jun 11, 2019. The investigators were Emmanuel J. Ramos and Lata Mathew. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmLTS Lohmann Therapy Systems Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LTS Lohmann Therapy Systems Corp.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected LTS Lohmann Therapy Systems Corp.?
Emmanuel J. Ramos and Lata Mathew are named on this Form 483, for the inspection of Jun 4 – Jun 11, 2019. Each investigator has a profile showing what they cite most.
When was LTS Lohmann Therapy Systems Corp. inspected by FDA?
The inspection ran Jun 4 – Jun 11, 2019, and the Form 483 is dated June 11, 2019.
How do I get the full Form 483 for LTS Lohmann Therapy Systems Corp.?
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