# FDA WARNING_LETTER - Deltex Pharmaceuticals Inc - July 15, 2008

Source: https://www.globalkeysolutions.net/records/warning_letter/deltex-pharmaceuticals-inc/6f6152ef-bf53-4d33-a175-8820ca26dce7

> FDA WARNING_LETTER for Deltex Pharmaceuticals Inc on July 15, 2008. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Deltex Pharmaceuticals Inc
- Inspection Date: 2008-07-15
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Deltex Pharmaceuticals Inc. (June 9 - July 15, 2008) revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm also markets unapproved new drugs, violating 21 U.S.C. § 355(a), and misbranded drugs under 21 U.S.C. §§ 352(f)(1) and 352(c).

Key violations include:
1.  **Quality Control Unit Deficiencies (21 CFR § 211.22(d)):** Failure to follow SOPs for spectrometer and balance calibration, and an inadequate Out-of-Specification (OOS) investigation procedure.
2.  **Inadequate Laboratory Controls for Components (21 CFR § 211.160(b)(1)):** FT-IR identity testing for tannate APIs was insufficient to detect physico-chemical changes or distinguish between compounds.
3.  **Lack of Scientifically Sound Specifications (21 CFR § 211.160(b)):** No specifications for free Tannic Acid, certain bulk ingredients, or dissolution/drug release for tannate products.
4.  **Insufficient Microbiological Testing (21 CFR § 21

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.globalkeysolutions.net/companies/deltex-pharmaceuticals-inc/5ffd5d31-7117-4fa6-9a7c-c3800e4c7827

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9