Enforcement Actions - Drug Manufacturers and Distributors
Enforcement/Disciplinary Actions are taken by regulatory authorities in response to a violation of the law or rules. Different kinds of actions may be taken depending on the severity of the offense, the history of previous violations, efforts made to correct the violation, the harm to the victims, the likelihood of a repeat violation, and other matters related to each particular case. These actions are taken to protect and promote the health, safety and welfare of the citizens of Texas.
| Name | License Number | City of Residence | Alleged Violation | Disciplinary Action | Date of Action |
|---|---|---|---|---|---|
| Krishe, Inc. | 1002667 | Friscoe, TX | 21 CFR §807.20 and 25 TAC §229.441(b), 21 CFR §807.81, 25 TAC §229.441(b), HSC §431.021(c), HSC §431.111(f)(1)(B), HSC §431.112(a)(1), and HSC §431.112(e)(1), 25 TAC §229.441(d)(3)(C), HSC §431.021(a), HSC §431.112(a)(1), HSC §431.112(e)(1), and 25 TAC §229.441(f), 21 CFR §803.18(d)(1) and 25 TAC §229.441(i), 21 CFR §803.17, 25 TAC §229.441(i), HSC §431.021(a), and HSC §431.112(r)(2) | Agreed to pay $16,000 | 7/15/21 |
| Advent Medical Inc., d/b/a Advent Resource Management | 0032904 | Houston, TX | 21 CFR, 211.22(d), 21 CFR 211.25(a) and 21 CFR 211.188 | Agreed to pay $2000.00 | 08/11/2020 |
| Quality Air Products, Inc. d/b/a Air Supply of North Texas | 0030520 | Dallas, TX | 21 CFR, 211.22(d), 21 CFR 211.25(a) and 21 CFR 211.188 | Agreed to pay $750.00 | 05/15/2020 |
| Dobbs Medical Sales, Inc. | 1000002 | Colleyville, TX | 25 TAC, 229.609(e) and 25 TAC, 229.611(d) | Respondent agrees to pay $1,000.00 | 08/20/2019 |
| Sylvia Penny, dba Aztlan Arts Tattoo Studio | 0084927 | Dallas, TX | 25 TAC, 229.408(b) and (c) | Admin Penalty of $2,000.00 paid $200.00 | 04/05/2019 |
| Paul Dunn, dba 3rd Eye Ink | 1004325 | Austin, TX | 25 TAC, 229.406(d) and (j) | Admin Penalty of $4,000.00 paid $400.00 | 04/01/2019 |
| Sisson Medical Products, LLC | 0090367 | Hurst, TX | 25 TAC 229.441(k)(3) and 431.21(a) | Agreed to pay $1,000.00 | 07/09/2018 |
| Medi 14 Inc., d/b/a Pearland Medical Supply | 1000872 | Pearland, TX | 25 TAC §229.441 (d)(3)(c) | Agreed to pay $500.00 | 08/22/2017 |
| Shawn Leonard, d/b/a Texas Oxycare, Inc. | 0036629 | San Angelo, TX | 25 TAC § 229.420(a)(14), 25 TAC § 229.429(a) and 21 CFR 205.50(g) | Agreed to Pay $500.00 | 08/14/2017 |
| San Antonio Extended Medical Care, Inc. d/b/aMed-Mart San Antonio | 0028624 | San Antonio, TX | HSC 431.11 1(a)(2)(B), HSC 431.021(b), 21 CFR 211.22(a), HSC 431.11 l(a)(2)(B), HSC 431.021(b) | Agreed to pay $500.00 | 07/12/2017 |
| Professional Welding Supply, Inc. | 0097235 | Houston, TX | 25 TAC § 229.420(a)(14), 25 TAC § 229.429(a) and 21 CFR 205.50(g) | Agreed to pay $500.00 | 05/22/2017 |
| JH2 Enterprises, LLC. d/b/a Infinity 13 Studio | 101581 | Farmersville, TX | 25 TAC, 229.407(d) | AdminPenalty of $2,000.00, Agreed to pay $200.00 | 03/30/2017 |
| Theo Killion, d/b/a Piercing Pagoda #709 | 0101431 | Irving, TX | 25 TAC, 229.404(f) | Admin penalty of $2,000.00, Agreed to pay $2,000.00 | 01/26/2017 |
| Ana Miriam Rodriguez, d/b/a Zamora’s tattoos | 0095388 | Irving, TX | 25 TAC, 229.407(d) | Admin Penalty of $5,000.00, Agreed to pay $500.00 | 01/17/2017 |
| Matheson Tri-Gas, Inc., d/b/a Matheson Tri-Gas 346 | 0069343 | Albuquerque, NM | 25 TAC § 229.420(a)(14), 25 TAC § 229.429(a) and 21 CFR 205.50(g) | Agreed to Pay $2,500.00 | 07/18/2016 |
| Downing Labs, LLC. | N/A | Lewisville, TX | §43 1.021 (a), (c), (e), (x), 43 1.114(a), 25 TAC §229.420(a)(1 1), (28), and 229.429(a) | Agreed to Pay $4,000.00 | 12/28/2015 |
| ABC Medical Equipment, Inc. | N/A | Rosenberg, TX | 25 TAC §229.251(d)(4)(E) | Agreed to Pay $500.00 | 10/25/2015 |
| Lone Star Dental Corp. | 0036001 | Arlington, TX | 25 TAC §229.611(1), 25 TAC 229.429(a), 25 TAC §229.420(a) and 21 CFR 205.50(g) | Agreed to Pay $1,000 | 04/12/2015 |
| Tony Serna, d/b/a HCT Wellness Center | N/A | Plano, TX | HSC §431.021(a), §431.021(c), §431.lll(f)(1)(B), §431.112(a), §431.1 12(c), §431.112(e), and §43 1.021(s) and HSC §431.182(a) and §431 .021 (f) | Agreed to Pay $1,000 | 03/02/2015 |
For enforcement questions or concerns, contact:
Jaime Wise
Phone: 512-834-4510
Penny Ravnell
Phone: 512-834-6785
Derrick Chelikowsky
Phone: 737-218-7081
Lanee Olaniyi-Oke
Phone: 737-218-7114
Ademola Olufemi
Phone: 737-218-7074