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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-98/
- Published: 2017-01-31T12:00:00.000Z
- Updated: 2026-09-14T22:03:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137871

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Biotronik SE & Co.** Berlin, Germany (9/1/16): FDA inspected the firm 3/2016 and cited GMP violations associated with the manufacture of Selectra percutaneous catheters, Galeo coronary guide wires, implantable pace makers, and implantable cardioverter defibrillators. For example, the inspection cited the firm’s validation of the process used to manufacture the coated Selectra Catheter lead introducer system because it lacked statistical rationale. Additionally, it said the firm failed to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.

[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538423.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538423.htm?ref=fdaweb.com)

**CTX Life Sciences** Surat, Gujarat, India (1/18): FDA inspected the firm 2/2016 and cited GMP violations associated with it active pharmaceutical ingredient manufacturing. For example, agency investigator observed rust, insects, damaged interiors, and drug residues in pieces of manufacturing equipment. The firm was also cited for releasing drug batches that were released without testing by ultraviolet spectrometry.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538693.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538693.htm?ref=fdaweb.com)

  
**FACTA Farmaceutici S.p.A** Milan, Italy (1/13): FDA inspected the firm 1/2016 and cited significant GMP violations (data integrity) for finished pharmaceuticals. For example, data involving multiple sterile drug product lots showed failing results, but the firm reported it showed passing results. The investigator also observed many copies of uncontrolled blank and partially-completed GMP forms (e.g., environmental monitoring recordings, OOS forms, water testing sheets, and clean room entry and exit logs). And, employees were observed using paper shredders to destroy critical laboratory and production records without the appropriate controls and procedures.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538068.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538068.htm?ref=fdaweb.com)

  
**Incyto Co., Ltd.** Chungnam-do, Republic of Korea (9/8/16): FDA inspected the (XXX INSERT XXX)firm 3/2016 and cited GMP violations related to its manufacturing of Class 1 devices (Incyto C-Chip-disposable hemocytometers). For example, the firm failed to establish and maintain procedures for implementing corrective and preventive actions. The firm also failed to ensure all complaints are evaluated to determine whether the complaint represents an event which is required to be reported under the Medical Device Reporting regulation.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538447.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538447.htm?ref=fdaweb.com)

**Pharmco Laboratories** Titusville, FL (12/15/16): FDA inspected the firm 11/2015 and cited GMP violations for both finished products and active pharmaceutical ingredients. An agency investigator found that the firm failed to establish adequate written procedures for production and process controls. The firm also had not validated the in-house assay methods developed for testing benzoyl peroxide and salicylic acid.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538730.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538730.htm?ref=fdaweb.com)

**Shina Corp.** Chongchungnam – Do Gong – Ju, Korea (8/23/16): FDA Inspected the firm 5/2016 and cited GMP violations with its manufacturing of hypodermic needles, piston syringes, and antistick syringes. For example, the firm failed to establish and maintain procedures for implementing corrective and preventive action. The investigator also cited the firm for failing to establish and maintain procedures to ensure that the device design is correctly translated into production specifications. Additionally, it was found that the firm failed to establish and maintain procedures for validating the device design.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538422.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm538422.htm?ref=fdaweb.com)